Events

Recall of Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 software

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01414-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01414-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    It has been identified that during an internal test, the left hand control (master) on the surgeon console moved unexpectedly upon the first entry into following mode. the system is in following mode when the surgeon is controlling the instruments at the surgeon console. this behaviour was determined to be associated with a software anomaly in the da vinci xi surgical system p5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances. certain interactions with the patient cart (during patient cart docking, or during multi-port procedures, repositioning the instrument arm) can trigger this behaviour upon entering following mode. the surgeon may receive a recoverable error, experience movement of the master controller and/or movement of the associated cannula/instrument in any direction including potential lateral movement. there is a remote probability of patient harm associated with this issue.
  • Action
    A software update will be released by Intuitive Surgical to address the anomaly which is expected in quarter 1 2017. In the interim, to prevent this event from occurring, users are advised to follow the instructions below during every da Vinci Xi procedure: 1.During Single-Site surgery, after installing each instrument on the sterile adapter, ensure instrument clutch is not activated and press the port clutch* button for that arm. This is only necessary at the beginning of the procedure, directly after the docking. 2.During Multi-Port surgery: - Immediately after docking to a cannula, press the corresponding port clutch button for that arm, and - If adjusting patient clearance and mid-procedure, ensure instrument clutch is not activated and press the corresponding port clutch button for that arm after the adjustment. This action has been closed-out on 11/05/2017.

Device

Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 soft...
  • Model / Serial
    Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 software Model Number: INS-IS4000ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd